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Status unknownNCT01295398Updated Aug 29, 2014

Influence of the Nebulizer on the Clinical Efficacy of Hypertonic Saline 3% in Children Aged Less Than 18 Months and Hospitalized With Acute Viral Bronchiolitis

An interventional study of nebulisations in Acute Viral Bronchiolitis, sponsored by Assistance Publique Hopitaux De Marseille. Status unknown at 1 site in France. Open to participants aged 28 Days to 18 Months. Per ClinicalTrials.gov, last updated 2014-08-29.

Sponsored by Assistance Publique Hopitaux De Marseille · Not applicable, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Mar 2011), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
168
Allocation
Randomized
Ages
28 Days to 18 Months
Sex
All
01

Study summary

The aim of the investigators study is to compare in children aged less than 18 months and hospitalized for an acute viral bronchiolitis the efficacy of the HS 3% (Mucoclear®, sterile ampoules of 4 ml) nebulised with a conventional jet-nebulizer (particles diameter of 4-5 µm), or with a jet-nebulizer adapted for infants (particles diameter of 2-2.5 µm), or with a mesh-nebulizer adapted for infants (particles diameter of 2-2.5 µm).

02

Conditions studied

  • Acute Viral Bronchiolitis

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03

In context

Bronchiolitis, Viral

30 studies on the registry are indexed under Bronchiolitis, Viral; 2 are open to participants now.

This study's planned enrollment of 168 is above the median of 85 across 25 interventional studies indexed under Bronchiolitis, Viral.

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Lead sponsor

Assistance Publique Hopitaux De Marseille is the lead sponsor of 702 studies on the registry; 139 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
28 Days to 18 Months
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Infant of less than 18 months old
  • infant hospitalized for a 1st episode of bronchiolitis defined as a 1st episode of respiratory difficulty with sibilant and\or crépitants in a viral context (head cold and\or cough and\or fever and\or notion of contage)
  • Necessity of an clinical score upper to 4. This clinical score, described by Wang in 1992, is the clinical score classically used in the studies concerning the acute(sharp) bronchiolitis of the infant ( 8,9,12 ). He(it) is at most on 12 points.
  • absence of respiratory décompensation requiring an admission in Unity of Pediatric Intensive care
  • signature of the
  • Membership in a national insurance

Exclusion criteria

Exclusion Criteria:

  • Refusal of the parents to participate in the study
  • 18-month-old infant hospitalized for acute(sharp) bronchiolitis with a clinical score lower than 4.
  • signs of respiratory décompensation requiring a transfer in resuscitation, signs of hypercapnie or episodes of apneas
  • histories of bronchiolitis or asthma of the infant
  • cardiac underlying pathology, respiratory, neuromuscular, immunodeficient or former premature of less of 34 weeks of amenorrhoea and less than 3 months of corrected age.
  • child having set within 6 hours preceding the inclusion a treatment by bronchodilatateurs or corticoids by systematic or inhaled way.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

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05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
168 participants (estimated)

Study arms

  • Other
    conventional jet-nebulizer

    (particles diameter of 4-5 µm)

    Device: nebulisations

  • Experimental
    a jet-nebulizer adapted for infants

    (particles diameter of 2-2.5 µm),

    Device: nebulisations

  • Experimental
    a mesh-nebulizer adapted for infants

    (particles diameter of 2-2.5 µm).

    Device: nebulisations

Interventions

  • Devicenebulisations
06

What researchers measure

Primary outcomes

  1. the improvement of the clinical score of severity at the 48th hour between the 3 groups of children

    Time frame: 12 months

Secondary outcomes

  1. the number of children requiring oxygen

    Time frame: 12 months

  2. tolerance of the nebulisations

    Time frame: 12 months

  3. the number of complications.

    Time frame: 12 months

  4. the number of parenteral nutrition

    Time frame: 12 months

07

Study locations

1 site
  • Assistance Publique Hopitaux de Marseille
    Marseille, 13354, France
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 29, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01295398
Responsible party
Sponsor
First posted
Feb 14, 2011
Start date
Dec 2010
Primary completion
May 2014
Completion
Nov 2014 (estimated)
Last update
Aug 29, 2014

Study contacts

BERNARD BELAIGUES
study director · Assistance Publique hôpitaux de Marseille

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2011. You cannot join it, but the record below documents what was studied.

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